Global Lead, Aseptic Facility & Utilities Design

Socket.dev; New Brunswick (NJ, MA); On-site; USD 162,000 - 196,000; Full time

Job summary

Bristol Myers Squibb is seeking an Associate Director, Aseptic Facility and Utility Design in New Brunswick, NJ. You will lead global aseptic facility and utility design standards, review design packages, URS, and qualification protocols, and partner with Engineering to ensure contamination control throughout capital projects.

You will provide QA governance for sterile design, support regulatory inspections, and drive alignment with EU GMP Annex 1 and FDA guidance, while mentoring teams across

Qualifications

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline required.
• 10+ years in sterility assurance, aseptic manufacturing or pharmaceutical quality with 4+ years in a leadership role.
• Technical expertise in aseptic processing, environmental monitoring, contamination control and risk assessment.
• Experience defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).
• Experience designing or overhauling CCS frameworks and APS/media fill programs at scale.
• Hands-on experience with sterilization validation and SUT qualification.

Responsibilities

• Review and approve risk assessments and quality impact assessments for contamination events around Facilities & Utilities.
• Lead and author high-complexity BTAs to support regulatory submissions and cross-site alignment.
• Develop investigation materials for aseptic and microbial issues and support regulatory inspections.

Skills

Aseptic processing

Contamination control

Regulatory inspections

Quality systems

Risk assessment

Design standards

Single-use tech

Sterilization

Cross-functional collaboration

Education

B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related discipline

Job description

Bristol Myers Squibb is seeking an Associate Director, Aseptic Facility and Utility Design in New Brunswick, NJ. You will lead global aseptic facility and utility design standards, review design packages, URS, and qualification protocols, and partner with Engineering to ensure contamination control throughout capital projects.

You will provide QA governance for sterile design, support regulatory inspections, and drive alignment with EU GMP Annex 1 and FDA guidance, while mentoring teams across